# K062029: Anatomical Shoulder Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Oct 31, 2006 after 105 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911686 (1991). 39 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 1.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K142403: Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System (2014), 5 descendants of its own
- K161620: Anatomical Shoulder Domelock Dome centric (2016), 3 descendants of its own
- K160085: Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System (2016), 3 descendants of its own
- K103404: ANA0TOMICAL Shoulder TM Combined System (2011), 3 descendants of its own
- K170711: ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (2017), 2 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0224-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0227-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0233-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 

## Indications for use
The Anatomical ShoulderTM Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following: * Complex 3 and 4 part fractures of the proximal humerus with subluxation of the head fragment; * Complex 3 and 4 part fractures of the proximal humerus with loosening of the spongiosa in the head fragment; * Complex 3 and 4 part fractures of the proximal humerus with additional cross split of the head fragment; * Fracture instability after osteosynthesis of 3 and 4 fragments of the proximal humerus; * Posttraumatic necrosis of the humeral head; * Posttraumatic arthrosis after humeral head fracture. The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

Source page: https://510kreport.com/device/K062029
Methodology: https://510kreport.com/methodology